1stOncology™: Cancer Intelligence Service – Page 14406 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

ArQule to Report First Quarter 2019 Financial Results on May 1, 2019

On April 17, 2019 ArQule, Inc. (Nasdaq: ARQL) reported it will report financial results for the first quarter of 2019 before the market opens on Wednesday, May 1, 2019 (Press release, ArQule, APR 17, 2019, View Source [SID1234535170]). The Company will hold a conference call and webcast on the same day at 9:00 a.m. ET to discuss these results and provide a general business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

AngioDynamics’ DIRECT Clinical Study Receives Institutional Review Board Approval for the Treatment of Stage III Pancreatic Cancer

On April 17, 2019 AngioDynamics, Inc. (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that the Company received central Institutional Review Board (IRB) approval to conduct its NanoKnife Irreversible Electroporation "Direct IRE Cancer Treatment" clinical study (DIRECT). The IRB approval closely follows the United States Food and Drug Administration’s (FDA) approval of AngioDynamics’ investigational device exemption (IDE) application announced on April 1 (Press release, AngioDynamics, APR 17, 2019, View Source [SID1234535169]).

Today’s approval enables AngioDynamics to accelerate its engagement with local IRBs and marks a significant milestone in the process of making Irreversible Electroporation (IRE) available to patients through the DIRECT clinical study. The Western IRB (WIRB) will serve as AngioDynamics’ IRB of record for the DIRECT clinical study.

"AngioDynamics is committed to providing physicians and patients with additional options for the treatment of Stage III pancreatic cancer. The DIRECT IRB approval demonstrates our commitment to initiating this next-generation clinical study as quickly as possible to advance our pursuit of innovative, lifesaving treatments," said Brent Boucher, AngioDynamics Senior Vice President and General Manager of Oncology.

AngioDynamics’ DIRECT clinical study features a comprehensive data collection strategy that will provide meaningful clinical information to healthcare professionals, support a regulatory indication for the treatment of Stage III pancreatic cancer, and facilitate reimbursement for hospitals and treating physicians. The next-generation study is classified as a Category B IDE by the FDA, allowing participating sites to obtain coverage for procedures performed as well as related routine costs.

The DIRECT clinical study comprises a Randomized Controlled Trial (RCT) at up to 15 sites, as well as a Real-World Evidence (RWE), next-generation registry at up to 30 sites, each with a NanoKnife System treatment arm and a control arm. AngioDynamics expects each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary endpoint of the study is overall survival.

As part of the DIRECT clinical study, AngioDynamics launched AngioDIRECT.com to facilitate the enrollment of participants. The online platform provides patients and their families with information about pancreatic cancer and details about the study. It also features a physician locator to help prospective participants and referring healthcare professionals identify clinical study locations.

The DIRECT clinical study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer.

Cell Medica Collaborator, Baylor College of Medicine, Showcasing Promise of CAR-NKT Therapies at American Society of Gene & Cell Therapy 22nd Annual Meeting

On April 17, 2019 Cell Medica, a leader in next-generation cellular immunotherapies for the treatment of cancer, reported that its collaborators from Baylor College of Medicine and Texas Children’s Hospital will be presenting the latest progress related to its innovative CAR therapy utilizing natural killer T cells (CAR-NKT) at the upcoming 22nd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) April 29 – May 2 in Washington, D.C (Press release, Cell Medica, APR 17, 2019, View Source [SID1234535168]).

Chris Nowers, Cell Medica’s CEO, said: "Our next-generation CAR-NKT platform combines the unique natural antitumor properties of NKT cells with innovative CAR constructs, enabling the possibility of producing multiple highly tumor-specific therapeutic products. We believe this approach could open up the broad potential of NKT cells to serve as a basis for off-the-shelf cell therapies targeting both solid and hematological tumors. We look forward to the important new updates that our collaborators at Baylor and Texas Children’s Hospital will be sharing at ASGCT (Free ASGCT Whitepaper)."

Details of the three oral presentations:

Harnessing Natural and Engineered Properties of iNKT Cells for Adoptive Cancer Immunotherapy
Presenter: Dr. Leonid Metelitsa, Professor of Pediatrics, Hematology-Oncology, Baylor College of Medicine
Session Title: NK cells Versus iNKT cells (Education Session)
Session Date/Time: Monday Apr 29, 2019 1:30 PM – 3:00 PM
Presentation Time: 1:30 PM – 2:00 PM
Room: Georgetown

NKT Cells Co-expressing a GD2-specific Chimeric Antigen Receptor and IL-15 Show Enhanced In Vivo Persistence and Antitumor Activity Against Neuroblastoma
Presenter: Dr. Andras Heczey, Assistant Professor of Pediatrics, Hematology-Oncology, Baylor College of Medicine
Session Title: Oral Abstract Session V
Session Date/Time: Tuesday Apr 30, 2019 8:00 AM – 10:00 AM
Presentation Time: 8:15 AM – 8:30 AM
Final abstract number: 367
Room: Heights Courtyard 3

Development of an Allogeneic Universally Tolerated NKT Cell Platform for Off-the-Shelf Cancer Immunotherapy
Presenter: Dr. Leonid Metelitsa, Professor of Pediatrics, Hematology-Oncology, Baylor College of Medicine
Session title: Cancer Gene Therapy
Session Date/Time: Wednesday May 1, 2019 3:45 PM – 5:30 PM
Presentation Time: 5:00 PM – 5:15 PM
Final abstract number: 682
Room: Monroe

The full abstracts can be accessed at: View Source

– ENDS –

Notes to Editors

About ASGCT (Free ASGCT Whitepaper)

The American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting provides an international forum where the latest gene and cell therapy developments are presented and critically discussed. As the leading American conference focusing solely on gene and cell therapy, ASGCT (Free ASGCT Whitepaper)’s annual meeting brings together more than 3,400 professionals including scientists, physicians, and patient advocates.

Find out more at: View Source

Media registration is open at: View Source

About GINAKIT2

GINAKIT2 is a first-in-human, dose escalation evaluation of CMD-501 in children with relapsed or refractory (R/R) high risk neuroblastoma (NCT03294954). Neuroblastomas occur primarily in children and account for 7-10 percent of all pediatric cancers. Ninety percent of patients are younger than 5 years at diagnosis. R/R high risk neuroblastoma is one of the deadliest types of childhood cancer and the current median survival is around 1-3 years. Almost all neuroblastomas express GD2, which is targeted by CMD-501. This study is supported by a grant from Alex’s Lemonade Stand Foundation (ALSF), awarded to Baylor College of Medicine investigators, Drs. Heczey and Metelitsa.

US Patent & Trademark Office Issues Patent on Anixa Biosciences CAR-T Cancer Treatment Technology

On April 17, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that the United States Patent and Trademark Office ("USPTO") has issued US Patent No. 10,259,855 (Press release, Anixa Biosciences, APR 17, 2019, View Source [SID1234535167]). This is the first patent covering Anixa’s CAR-T cancer treatment technology.

The patent is titled "METHODS AND COMPOSITIONS FOR TREATING CANCER," and the inventors are Drs. Jose Conejo-Garcia and Alfredo Perales-Puchalt. Dr. Conejo-Garcia is the Chair of the Department of Immunology at Moffitt Cancer Center and Dr. Perales-Puchalt is a Senior Postdoctoral Fellow in The Wistar Institute’s Vaccine & Immunotherapy Center. The patent is assigned to The Wistar Institute and Anixa Biosciences’ majority-owned subsidiary, Certainty Therapeutics, Inc. is the exclusive, world-wide licensee.

Dr. Amit Kumar, Anixa’s Chairman, President and CEO, stated, "The claims of this patent were allowed in January of this year as noted in a previous announcement, and we are pleased that this key patent has now issued. Those interested in reviewing the patent can now read the content." Dr. Kumar continued, "This technology takes advantage of specific hormone–hormone receptor biology to address malignancies and may hold promise to be the one of the first successful CAR-T therapies against solid tumors. While our initial focus is the treatment of ovarian cancer, the technology covered by the patent is broad and may also be effective in treating other solid tumors by exploiting an anti-angiogenesis mechanism of action. Anixa and its research and clinical development partner, the Moffitt Cancer Center, hope to file an IND application for this therapy later this year."

Genmab Announces Data to be Presented at 2019 ASCO Annual Meeting

On April 17, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that 14 industry sponsored abstracts regarding Genmab programs were accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from May 31 to June 4, 2019 (Press release, Genmab, APR 17, 2019, View Source [SID1234535166]). The titles of the abstracts are currently available on the ASCO (Free ASCO Whitepaper) iPlanner website, with the full abstracts scheduled to be published on May 15, 2019. A list of accepted industry sponsored abstracts is provided below, and includes ten daratumumab abstracts, two of which were accepted for oral presentations, one abstract on enapotamab vedotin, and two abstracts on tisotumab vedotin (Trial in Progress abstracts).

"We are pleased that once again a wide selection of abstracts concerning Genmab proprietary and partnered programs was selected for presentation at the prestigious ASCO (Free ASCO Whitepaper) Annual Meeting. We are especially looking forward to the first full presentations of data from the COLUMBA and CASSIOPEIA daratumumab Phase III trials," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are equally excited to begin sharing with the oncology community early data from enapotamab vedotin and ongoing trials in progress for tisotumab vedotin."

Representatives from Genmab will be in attendance at ASCO (Free ASCO Whitepaper), booth #24159.

List of Industry Sponsored Abstracts:

Daratumumab (Submitted by Janssen Biotech, Inc.):
Phase 3 Randomized Study of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) Vs VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: CASSIOPEIA Part 1 Results – Oral presentation, Sunday, June 2, 10:45 AM – 10:57 PM CDT

Efficacy and Safety of the Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA – Oral presentation, Sunday, June 2, 11:09 AM – 11:21 AM CDT

Efficacy of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) in Transplant-eligible Newly Diagnosed Multiple Myeloma Based on Minimal Residual Disease Status: Analysis of the CASSIOPEIA Trial –Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Stem Cell Yield and Transplantation Results from Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) in the Phase 3 CASSIOPEIA Study –Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Impact of age on efficacy and safety of daratumumab in combination with lenalidomide and dexamethasone (D-Rd) in patients with transplant-ineligible newly diagnosed multiple myeloma: MAIA – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Faster and sustained improvement in health-related quality of life for newly diagnosed multiple myeloma patients ineligible for transplant treated with daratumumab, lenalidomide, and dexamethasone (D-Rd) vs Rd alone: MAIA – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Efficacy and safety of daratumumab, bortezomib, and dexamethasone (D-Vd) in relapsed or refractory multiple myeloma based on cytogenetic risk: updated subgroup analysis of CASTOR – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Efficacy and safety of daratumumab, lenalidomide, and dexamethasone (D-Rd) in relapsed or refractory multiple myeloma: updated subgroup analysis of POLLUX based on cytogenetic risk – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Bortezomib, lenalidomide, and dexamethasone (VRd) ± daratumumab in patients with transplant-eligible newly diagnosed multiple myeloma: a multicenter, randomized, phase 3 study (PERSEUS) – Poster, Monday, June 3, 8:00 AM – 11:00 AM CDT

Bortezomib, lenalidomide, and dexamethasone (VRd) ± daratumumab in patients with newly diagnosed multiple myeloma for whom transplant is not planned as initial therapy: a multicenter, randomized, phase 3 study (CEPHEUS) – Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT

Tisotumab vedotin (Submitted by Seattle Genetics):
SGNTV-001: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or
Metastatic Disease in Solid Tumors – Poster presentation, Saturday, June 1, 2019, 8:00 AM – 11:00 AM CDT

Phase 2 Trial of Tisotumab Vedotin in Platinum-Resistant Ovarian Cancer (innovaTV 208) – Poster presentation, Saturday, June 1, 2019, 1:15 PM – 4:15 PM CDT

Enapotamab vedotin:
First-in-human, dose-escalation, phase 1 trial to evaluate safety of anti-Axl antibody–drug conjugate enapotamab vedotin in solid tumors – Poster presentation, Saturday, June 1, 2019, 8:00 AM – 11:00 AM CDT

Ofatumumab (Submitted by Novartis):
Long-term follow-up of previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) treated with ofatumumab and chlorambucil: Final analysis of the phase 3 COMPLEMENT 1 trial –Poster presentation, Monday, June 3, 8:00 AM – 11:00 AM CDT